BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS BRCH SZ B HI 60MM

    MDR report key: 10777974 · Received November 3, 2020

    Report

    Report Number
    0001825034-2020-03978
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Report Date
    December 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE INNER STERILE PACKAGING AND OUTER CARTONS ARE DAMAGED. STERILITY HAS BEEN COMPROMISED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET CONTROL WAS CONFORMING TO SPECIFICATIONS. THE ROOT CAUSE IS ATTRIBUTED TO TRANSIT DAMAGE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DEVICE RETURNED WITH PACKAGING DAMAGE AND STERILITY BARRIER COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241907 ARCOS BRCH SZ B HI 60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 371680

    Patients

    Seq Age Sex Outcome Treatment
    1